Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Break (1069)
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Patient Problems
Stroke/CVA (1770); Bone Fracture(s) (1870); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Myocardial Infarction (1969); No Code Available (3191)
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Event Date 12/17/2014 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Patient: surgical intervention.Please note, there is insufficient information currently provided to determine what implant is the subject of the alleged bone and implant fracture.Therefore, the stem will be reported to capture the alleged events.If/when further information is received, it will be evaluated and submitted if applicable at that time.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Ppf and implant records received.Ppf alleges pseudotumor, stroke, heart attack, bone fracture, component fracture, and infection.Doi: (b)(6) 2014; dor: (b)(6) 2014; (left hip).This pc is for the second revision of the left hip.See (b)(4) for the first revision.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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